1.3 Development of Bt brinjal by M/s Mahyco 11 SECTION II: REVIEW OF STATUS OF REGULATORY COMPLIANCE 15 2.1 Approvals taken by M/s Mahyco 15 2.2 Compliance with the Revised guidelines for research in transgenic 17

BACKGROUND M/s Maharashtra Hybrid Seeds Company Limited (Mahyco) has developed transgenic brinjal plants expressing cry1Ac gene isolated from Bacillus thuringiensis tolerant to the fruit and shoot borer (herein after referred to as Bt brinjal), one of the major pests which attacks the brinjal crop throughout its life cycle. The transformation was carried out using genetic engineering techniques viz. Agrobacterium tumefaciens mediated method. Bt brinjal contains three genes namely: 1. The cry1Ac gene derived from Bacillus thuringiensis (Bt) to produce an

3. The aad gene for another marker O-aminoglycoside adenyl trans ferase. M/s Mahyco has applied to the Genetic Engineering Approval Committee (GEAC) for environmental release of Bt brinjal. The development of Bt brinjal was initiated in 2000 in accordance with the regulatory procedures prescribed under Rules for the Manufacture, Use, Import, and Export and Storage of Hazardous Micro Organisms / Genetically Engineered Organisms or Cells, 1989, hereafter referred as Rules 1989 issued by the Ministry of Environment and Forests (MoEF) under the provisions of the Environment (Protection) Act (EPA), 1986. The chronology of Bt brinjal development is discussed in Section I of this report. Bt brinjal has been evaluated for its efficacy and safety as per the protocols and procedures prescribed under the Rules 1989 and relevant biosafety guidelines. The Review Committee on Genetic Manipulation (RCGM) in its 40th meeting held on April 25, 2006 considered in detail the data generated by M/s Mahyco to establish the efficacy and safety of the inserted gene. The RCGM concluded that Bt brinjal is effective in controlling target pests, safe to the environment, non toxic, non- allergenic and has potential to benefit the farmers. RCGM recommended that GEAC may consider granting approval for conduct of large scale field trials on Bt brinjal as per the protocols submitted by M/s Mahyco. The request of M/s Mahyco and recommendations of the RCGM for conduct of large scale field trials and seed production were considered by the GEAC in its 68th meeting held on June 1, 2006. In accordance with the decision taken in the above meeting, summary of biosafety data was posted on the GEAC website (http://envfor.nic.in) for inviting public comments. Subsequently, the GEAC constituted an Expert Committee on Bt Brinjal under the chairmanship of Dr. Deepak Pental, Vice Chancellor, Delhi University (herein after referred as EC-I). The EC-I reviewed the biosafety data submitted by M/s Mahyco as well as the

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submissions received from several stakeholders. The EC-I submitted its recommendations to the GEAC in July 2007. Recommendations of the EC-I are discussed in Section II of this report. Further, in accordance with the Honble Supreme Court directions dated May 8, 2007, the biosafety dossier on Bt brinjal was posted on the GEAC website. Based on the recommendations of the EC-I, the GEAC in its 79th meeting held on August 8, 2007, permitted the conduct of large scale trials (LST) of Bt brinjal for two seasons under the direct supervision of Director, Indian Institute of Vegetable Research (IIVR), Varanasi and to conduct some additional biosafety related studies by M/s Mahyco. The field trials were subject to compliance of the following conditions:

of at least 0.01% to detect and confirm that there has been no contamination. 3. Designating a lead scientist who would be responsible for all aspects of the

trials including regulatory requirements. The GEAC has received the final reports from IIVR and M/s Mahyco. The GEAC has also received several representations on concerns to human health and environment from Bt brinjal. Issues raised by the NGOs and other stakeholders are discussed in Section V of this report. To review the findings of the LST and other studies on Bt brinjal as well as address the concerns expressed in various representations, the GEAC has constituted an 'Expert Committee' in accordance with the decision taken in the 91st GEAC meeting held on January 14, 2009 (hereinafter referred to as EC-II). The composition of the EC-II is as follows:

19. Letter from Ms Kavitha Kurgunti to members of the EC-II constituted on May 29, 2009, to review the biosafety studies and large scale trials of Bt Brinjal.

20. Appeals submitted to PMO.

21. I AM NO LAB RAT CAMPAIGN

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Two meetings of the EC-II were held on July 30, 2009 and August 31, 2009 under the chairmanship of Prof. Arjula R. Reddy, Co-chairman GEAC. The deliberations of the EC-II are elaborated in the subsequent sections as given under:

I. Development of Bt brinjal in India II. Review of status of regulatory compliance

i. Approvals taken by M/s Mahyco.

ii. Compliance with the Revised guidelines for research in transgenic plants & guidelines for toxicity and allergenicity evaluation of transgenic seeds, plants and plant parts, 1998.

iii. Compliance with regulatory conditions stipulated by GEAC in the permit letter for large scale trials, 2007

iv. Compliance with the Guidelines for the Safety Assessment of Foods Derived from Genetically Engineered (GE) Plants, 2008

III. Review of Bt brinjal safety assessment dossier

i. Nature and effect of gene modification

ii. Environmental safety

iii. Food and feed safety

IV. Review of efficacy and agronomic performance V. Consideration of issues raised by NGOs, national and international groups VI. Summary and recommendations

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SECTION I DEVELOPMENT OF Bt BRINJAL BY M/S MAHYCO IN INDIA

1.1 BRINJAL AS A CROP

Brinjal, Solanum melongena Linn., is one of the principal vegetable crops grown in many geographical parts in India. The area under brinjal cultivation is estimated at 0.512 million ha with production of 8.4 million metric tonnes in 2007 (FAOSTAT, 2007). This accounts for 8.14% of area under vegetable cultivation with a contribution of 9% to total vegetable production. Brinjal is primarily grown by small farmers and is thus an important source of income for them. It is a versatile crop, adapted to different agro -climatic regions and can be grown throughout the year. A number of cultivars are grown in the country, consumer preference being dependent upon fruit colour, size and shape. The fruits are consumed as cooked vegetables in various ways, and dried stem are used as fuel in rural areas.

1.2 RATIONALE FOR THE DEVELOPMENT OF Bt BRINJAL 1.2.1 Economic loss due to pest damage

Damage by insect pests is a major problem in brinjal production. Leucinodes orbonalis (Guen....